BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 15759348 · Received November 9, 2022

    Report

    Report Number
    2210968-2022-09270
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    July 29, 2022
    Report Date
    November 9, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). DEVICE NOT RETURNED. RELATED EVENTS CAPTURED VIA 2210968-2022-09269. CITATION: SURGICAL NEUROLOGY INTERNATIONAL ¿ 2022 ¿ 13(328). PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: IMPAIRED WOUND HEALING FOLLOWING CRANIAL VAULT RECONSTRUCTION IN A PATIENT WITH AN ATYPICAL PHENOTYPE OF MARFAN SYNDROME: A CASE REPORT. THIS STUDY PRESENTS A CASE REPORT OF AN INFANT FOUND TO HAVE CLINICAL MANIFESTATIONS TYPICALLY ASSOCIATED WITH LOEYS-DIETZ SYNDROME (LDS), BUT WHOSE GENOTYPE WAS POSITIVE FOR A PATHOGENIC VARIANT IN THE FNB1 GENE CONSIDERED DIAGNOSTIC OF MARFAN SYNDROME (MFS). A 7-MONTH-OLD FEMALE PRESENTED TO THE CRANIOFACIAL CENTER OF WESTERN NEW YORK FOLLOWING A GENETICS CONSULTATION THAT RAISED CONCERN FOR LOEYS-DIETZ SYNDROME (LDS) WITH POSSIBLE CRANIOSYNOSTOSIS. THE PARENT¿S CHIEF COMPLAINT WAS THE APPEARANCE OF THE PATIENT¿S HEAD SHAPE AND ORBITS. SHE HAD A PECTUS EXCAVATUM DEFORMITY, ARACHNODACTYLY, AND LONG NARROW FEET WITH LONG TOES. SHE WAS ALSO NOTED TO HAVE A NARROW POINTED MENTON. AN INITIAL ECHOCARDIOGRAM WAS NORMAL, BUT A FOLLOW UP STUDY DISCLOSED MITRAL VALVE PROLAPSE, MILD-TO-MODERATE MITRAL VALVE REGURGITATION, AND MILDLY DILATED AORTIC SINUSES AND ASCENDING AORTA. THE SKULL RADIOGRAPH SKULL RADIOGRAPH IDENTIFIED METOPIC SUTURE CRANIOSYNOSTOSIS . AFTER EVALUATION AT THE CRANIOFACIAL CLINIC AT 7 MONTHS OF LIFE, A CT SCAN OF THE HEAD REVEALED VERY MILD HYPOTELORISM, BITEMPORAL NARROWING, AND PROMINENT RIDGING WITH COMPLETE SYNOSTOSIS OF THE METOPIC SUTURE . THE PARENTS ELECTED TO PROCEED WITH FRONTO-ORBITAL ADVANCEMENT AND ANTERIOR CRANIAL VAULT EXPANSION AND REMODELING. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AT AGE 9 MONTHS. DURING SURGERY, SIGNIFICANT ABNORMALITIES NOTED INCLUDED THE THIN AND FRAGILE NATURE OF THE PATIENT¿S DURA AND WEAK AND FRIABLE DERMIS OF THE SCALP. THE GALEA AND DERMIS WERE CLOSED WITH 3-0 COATED POLYGLACTIN 910 BRAIDED ABSORBABLE SUTURE (VICRYL, ETHICON, INC., JOHNSON AND JOHNSON CO, RARITAN, NJ). DURING CLOSURE, THE GALEA AND DERMIS TOLERATED ONLY MINIMAL TENSION BEFORE STITCHES WOULD PULL-THROUGH. THE DERMIS APPEARED ATROPHIC TO ALMOST NONEXISTENT. SKIN WAS CLOSED WITH 4-0 VICRYL RAPIDE¿ SUTURE (ETHICON, INC., JOHNSON AND JOHNSON CO, RARITAN, NJ) IN A RUNNING FASHION. PRIMARY CLOSURE WAS ACHIEVED. THE PATIENT WAS DISCHARGED TO HOME ON POSTOPERATIVE DAY 4. AT 4 WEEK FOLLOW-UP, THE PATIENT WAS NOTED TO HAVE A SMALL AREA OF DEHISCENCE AT THE RIGHT SCALP INCISION. THERE WAS NO ACTIVE INFECTION AND WOUND CARE WAS STRESSED TO THE PATIENT¿S PARENTS IN HOPES OF SECONDARY WOUND HEALING. THE PATIENT PRESENTED 1 MONTH LATER FOR FOLLOW-UP AND WAS NOTED TO HAVE A 2 CM × 2 CM AREA OF ULCERATED SKIN AT THE LATERAL ASPECT OF THE RIGHT SCALP FLAP. AGAIN, THIS DID NOT APPEAR TO BE ACTIVELY INFECTED, BUT WAS FAILING TO HEAL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR WOUND DEBRIDEMENT AND SCALP CLOSURE, AFTER WHICH THE WOUND HEALED WELL WITHOUT FURTHER COMPLICATION. IT WAS CONCLUDED , THAT PHENOTYPIC OVERLAP BETWEEN GENETIC DISORDERS CAN CONFOUND CLINICAL DIAGNOSIS AS ILLUSTRATED IN THIS CASE. GENETIC TESTING CAN BE HIGHLY VALUABLE IN THE DIAGNOSIS OF CLINICALLY VARIABLE DISORDERS. PATIENTS WITH MARFAN SYNDROME (MFS) WHO UNDERGO CRANIAL SURGERY MAY BE AT INCREASED RISK FOR WOUND HEALING COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2951347 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Female Required Intervention